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Certification and Auditing Services for Medical Devices

Manufacturers of medical devices are held to an extremely high standard. Regulatory bodies, hospitals, health care practitioners and patients expect the devices used to treat and heal illnesses and injuries to be safe and to perform as promised. The stakes are high in this sector, and the level of technology unmatched. It takes teamwork to succeed in this market, to be competitive, to establish a reputation for reliability and to stay abreast of new scientific and regulatory developments. We are valuable team players with the skills, stamina and specialized services necessary to assist you in producing and operating the most effective, technologically sophisticated and safest products for the medical sector. Benefit from our comprehensive services, fast lead times and our long-standing experience in the field of medical devices.

Application for designation under the Medical Device Regulation (MDR) 2017/745

Notified Bodies are allowed to apply first-time since November 26, 2017 for designation under the Medical Device Regulation (MDR) 2017/745. We are glad to inform you, that our application is already filed and covers a comparable scope as currently maintained by us.

Unannounced audits

Commission Recommendation of 24th September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU) was published on 24 September 2014 and entered into legal force on 25 September 2013 by publication in the Official Journal of the European Communities.